Senior APQR & Quality Systems Engineer

Tris Pharma, Inc.; South Brunswick (NJ); On-site; USD 100,000 - 145,000; Full time

Benefits offered by this job

Bonus eligible

Medical/dental/vision insurance

401K with match

Life insurance

PTO

Job summary

Tris Pharma, Inc. seeks a Senior Quality Systems Engineer/APQR Lead to strengthen QA by merging data evaluation with engineering controls to ensure product quality. You will lead data trends, APQRs/APRs and regulatory readiness across production and laboratory systems.

The role requires 5+ years in quality systems within pharma/biotech, fluency in English, and strong statistical/data-analysis skills to drive continuous improvement and compliance.

Qualifications

• Bachelor's degree in a scientific field and 5+ years in quality systems, process validation or quality engineering in pharma/biotech.
• Strong knowledge of FDA 21 CFR Part 210/211, ICH Q8/Q9/Q10 and quality risk management.
• Experience with data analysis, trend reporting and regulatory audits.

Responsibilities

• Maintains all quality documentation in line with SOPs and cGMPs.
• Leads evaluation of annual product quality data to identify risks and opportunities for improvement.
• Hosts APR risk assessment meetings and tracks action items.
• Performs advanced trend analysis on CQAs/CPPs across multiple batches.
• Analyzes large datasets from manufacturing, packaging, lab, deviations and CAPAs to identify trends.
• Applies statistical methods (control charts, regression, ANOVA) to assess process health.
• Drives root cause investigations with QA, production and lab teams.
• Monitors process capability indices (Cpk, Ppk) and supports inspections and regulatory audits.

Skills

Fluent English

Analytical thinking

Strong communication

Independent

Education

Bachelor's degree in Chemical Eng / Pharmaceutical Sci / Chemistry

Tools

Minitab

JMP

SAS

Power BI

Tableau

Job description

Tris Pharma, Inc. seeks a Senior Quality Systems Engineer/APQR Lead to strengthen QA by merging data evaluation with engineering controls to ensure product quality. You will lead data trends, APQRs/APRs and regulatory readiness across production and laboratory systems.

The role requires 5+ years in quality systems within pharma/biotech, fluency in English, and strong statistical/data-analysis skills to drive continuous improvement and compliance.